MISC-CBO in Children Affected by HIV/AIDS

NCT04359043 | Completed DMC

• 1 other identifier: 15598-02
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, 12 million children in Sub-Saharan Africa and 1.9 million children in South Africa (SA) are orphaned by HIV/AIDS. Research addressing what can be done to support these children has been limited, clustered and of variable quality. Our prior work showed that an important support structure for care of HIV affected children (orphans) in SA is through Community Based Organizations (CBOs). Currently, no evidence-based CBO intervention exist. CBO careworkers report low efficacy in addressing the mental health and cognitive developmental needs of children. There is therefore a critical need to empower frontline CBO careworkers to be trained in addressing the mental health and cognitive developmental needs of orphans. The Mediational Intervention for Sensitizing Caregivers (MISC) used in our previous work with parents in Uganda holds promise. The objective in this application is to use a mixed methods approach (observations, focus groups, questionnaires) to test the acceptability and feasibility of adapting MISC to be used by CBO careworkers instead of parents (MISC-CBO), and to assess preliminary outcomes. Guided by the Mathews and Hudson's framework for evaluating caregiver-child training programs, our approach will consist of three phases: Adapt, Process evaluation, Outcome evaluation. In Phase 1 (Adapt, Year 1) we will conduct formative research (qualitative interviews and focus groups) with community stakeholders, a Community Advisory Board and children to ascertain feasibility and acceptability of MISC-CBO in the SA cultural context with 7-11 year old AIDS orphans. In Phase 2 (Implementation and process evaluation, Year 2) we will recruit 80 AIDS orphans through 4 CBOs (20 children and 4 careworkers from each CBO). Two CBOs will be allocated to MISC-CBO and 2 will be allocated to treatment as usual (TAU of comparable contact hours). One year of bi-weekly (every 2 weeks) intervention sessions will be conducted. Process evaluation will include individual interviews, observations, focus groups and questionnaire-based assessment of MISC-CBO feasibility, adherence and fidelity. In Phase 3 (Outcomes assessment, Years 2 \& 3) the effects of MISC-CBO to promote mental health and cognitive development through the mechanism of improved quality of caregiving by CBO careworkers will be assessed through mental health and cognitive assessments at baseline (beginning of Year 2), 6, 12 and 18 months compared to TAU in the children and careworkers recruited in Phase 2. At the end of this formative RO1 that transforms a parent intervention into a CBO careworker intervention, we will have established the foundational assessments and intervention to apply for an RO1 to evaluate a randomized controlled trial designed to fully test the efficacy of MISC-CBO during the critical developmental window of at-risk HIV affected children aging into adolescence. This project will make possible the only culture-appropriate and sustainable evidence-based CBO intervention that can be readily and effectively implemented globally in low-resource settings with children generally at risk from disease, malnutrition and neglect.

Conditions

HIV Affected Children (Single and/or Double Orphans)

Outcome Measures

Primary Outcomes (9)

• Change in Strengths and Difficulties Questionnaire (SDQ) Total Score as index of improvement in overall mental health in children

  The Strengths and Difficulties Questionnaire (Goodman, 2001) is a well validated measure of mental health in children. While the measure covers several domains of emotional-behavioral psychiatric symptoms (anxiety, depression, conduct problems, peer problems and prosocial behavior), it is most often summed to derive a total score to index overall level of mental health problems in children. The use of this measure in this way has been validated in a Sesotho speaking population of children where it was shown that the total score provides a good index of mental health problems in HIV/AIDS affected children (Sharp et al., 2014). This measure has also been shown to be sensitive to change and therefore serves as a good outcome measure to assess overall improvement in mental health as a function of our behavioral intervention.

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Focus the child.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The cognitive components include the following subscale: Focusing, Providing meaning, Expanding, Regulating, and Rewarding. The Focusing subscale assesses the caregiver's capacity to focus the child's attention on a topic or object. It is the first step in providing a mediational learning experience for a child and one of the outcomes that the MISC intervention targets. The OMI tallies each instance when Focusing occurs during a 7-minute video-taped interaction. This is the unit of measurement for the OMI Focusing outcome that will be assessed here. An example of a behavior that is coded as Focusing is: "Look here!".

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Provide meaning to the child's subjective experience.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The cognitive components include the following subscale: Focusing, Providing meaning, Expanding, Regulating, and Rewarding. The Provision of meaning subscale assesses the caregiver's capacity to describe the subjective experience of the child. The OMI tallies each instance when Provision of meaning occurs during a 7-minute video-taped interaction. This is the unit of measurement for the OMI Provision of meaning outcome that will be assessed here. An example of a behavior that is coded as Provision of meaning is: "This is a butterly!"

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Expand the child's learning.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The cognitive components include the following subscale: Focusing, Providing meaning, Expanding, Regulating, and Rewarding. The Expanding subscale assesses the caregiver's capacity to expand the child's learning around the topic under discussion. The OMI tallies each instance when Expanding occurs during a 7-minute video-taped interaction. This is the unit of measurement for the OMI Expanding outcome that will be assessed here. An example of a behavior that is coded as Expanding is: "Butterflies are important for pollination of flowers".

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Regulate the child.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The cognitive components include the following subscale: Focusing, Providing meaning, Expanding, Regulating, and Rewarding. The Regulating subscale assesses the caregiver's capacity to regulate the child's learning around the topic under discussion. The OMI tallies each instance when Regulating occurs during a 7-minute video-taped interaction. This is the unit of measurement for the OMI Regulating outcome that will be assessed here. An example of a behavior that is coded as Regulating is: "To build the tower, we must first put down the big block; then you can put down the small block".

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Reward the child.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The cognitive components include the following subscale: Focusing, Providing meaning, Expanding, Regulating, and Rewarding. The Rewarding subscale assesses the caregiver's capacity to reward the child during interaction. The OMI tallies each instance when Rewarding occurs during a 7-minute video-taped interaction. This is the unit of measurement for the OMI Rewarding outcome that will be assessed here. An example of a behavior that is coded as Rewarding is: "Well done. You were very careful in placing the blocks on top of each other so that they don't fall down".

  baseline, 6 months follow-up, 12 months follow-up

• Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to utilize affective components.

  The OMI is an observational measure of caregiver-child interactions. Interactions between caregiver and child are video-recorded and the components of a mediated learning experience is then coded using the OMI coding manual. Mediated learning components include two sets of measurements: cognitive and affective components. The affective components are several behaviors that the observer codes, each on a 5 point scale. These include smiling, synchrony, turntaking, touching, validating, and positive affect. The scores on each of these behaviors are then totaled to provide a total score on affective components observed during the 7-minute videotaped interaction.

  baseline, 6 months follow-up, 12 months follow-up

• Change in the Kaufman Brief Intelligence Test (KBIT) overall IQ composite

  The Kaufman Brief Intelligence Test (KBIT) (Kaufman \& Kaufman, 2004) is a brief, individually administered measure of verbal (vocabulary subtest) and non verbal (Matrices subtest) intelligence. It can be used with those aged 4-90 years old and takes between 15-30 minutes to administer. The KBIT-2 generates three scores: Verbal, Non Verbal and an overall IQ composite. Theoretically the verbal subtests measure crystallised ability and the non verbal subtests measure fluid reasoning. The KBIT has been used successfully in South Africa (Ogunlade, A.O., et al.2011) and neuropsychologist and Co-Investigator Boivin has been using it in Johannesburg in yet unpublished work with the relevant population for the current research. The overall IQ composite will be used to assess change in cognitive outcomes as a function of the MISC intervention.

  baseline, 6 months follow-up, 12 months follow-up

• Change in Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite score to assess change in executive functions as a function of the intervention.

  The Behavior Rating Inventory of Executive Function (BRIEF-) (Gioia et al., 2003) is useful for evaluating and planning treatment strategies for a wide spectrum of developmental and acquired neurological conditions, including learning disabilities, low birth weight, ADHD, Tourette's disorder, traumatic brain injury, and autism. These scales include the behavior/cognitive functions of Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor. Given this focus, the BRIEF will complement, rather than overlap with the Strengths and Difficulties Questionnaire used for more general mental health problems. The eight non-overlapping clinical scales form two broader indexes: Behavior Regulation (three scales) and Metacognition (five scales). A Global Executive Composite score is also produced. This is our principal outcome measure from this assessment. A Sesotho version of the measure was obtained through the publisher.

  baseline, 6 months follow-up, 12 months follow-up

Study Arms (2)

Mediational Intervention for Sensitizing Caregivers

EXPERIMENTAL

Half of the child participants and the careworkers in the Community-based Organization taking care of them, received the Mediational Intervention for Sensitizing Caregivers.

Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

Treatment as Usual

OTHER

The other half of child participants and the careworkers in the Community-based Organization taking care of them, received Treatment as Usual which consists of the usual services delivered to children at the CBO: food, help with homework, registrations for birth certificates.

Behavioral: Treatment as Usual

Interventions

Mediational Intervention for Sensitizing Caregivers (MISC) BEHAVIORAL

MISC is an intervention that focuses on increasing the caregiving capacity of the caregiver by enhancing a set of emotional and cognitive components that collectively, sensitizes the caregiver to the emotional and cognitive needs of the child.

Mediational Intervention for Sensitizing Caregivers

Treatment as Usual BEHAVIORAL

Treatment as Usual was delivered by community-based organization caseworkers. It consists of a nutritional curriculum of the same dosage and time commitment as the experimental condition, but with no caregiving component.

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• orphaned (UNICEF criterion of one or both parents deceased from AIDS)
• HIV/AIDS affected child as determined by verbal autopsy measure to determine cause of death of biological parent(s)
• year old
• resident in the CBO catchment area
• principle home caregiver of the child should be able to participate in baseline and follow-up assessments

You may not qualify if:

• medical history of serious birth complications
• severe malnutrition, bacterial meningitis
• encephalitis
• cerebral malaria
• known brain injury or disorder requiring hospitalization
• continued evidence of seizure or other neurological disability
• HIV infection

Sponsors & Collaborators

• University of Houston: lead
• University of the Free State: collaborator
• Michigan State University: collaborator
• Bar-Ilan University, Israel: collaborator

Study Sites (1)

Community Development Support Center, UFS

Bloemfontein, Free State, 9301, South Africa

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This was a quasi-experimental study with two treatment arms: intervention vs. TAU. Subjects were not randomized.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 24, 2020
• Study Start: February 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

ZA (1)